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A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer
NCT06774131 · View on ClinicalTrials.gov ↗
Study Summary
This study will evaluate the efficacy and safety of UGN-104, a new formulation of UGN-101 (approved in the United States and Israel as JELMYTO \[mitomycin\] for pyelocalyceal solution), instilled in the upper urinary tract (UUT) of patients with low-grade upper tract urothelial cancer (LG-UTUC).
Conditions Studied
Interventions
- DRUG UGN-104
Study Locations (20)
Florida
- BioResearch Partners Aventura — Aventura
- UF Health Cancer Center University of Florida — Gainesville
- BioResearch Partners Hialeah — Hialeah
South Carolina
- Medical University of South Carolina — Charleston
- Carolina Urologic Research Center, LLC — Myrtle Beach
- Low county Urology Clinics — North Charleston
Texas
- Amarillo Urology Research — Amarillo
- UPNT Research Institute, LLC — Arlington
- Texas Urology Specialists-Austin — Austin
California
- Michael G Oefelein Clinical Trials — Bakersfield
- University of California, Irvine — Orange
Other
- MHAT Haskovo AD — Haskovo
- University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov," Sofia, Clinic of Urology — Sofia
Alabama
- Urology Centers of Alabama — Homewood
Arizona
- Arizona State Urological Research Institute, LLC ("ASURI") — Chandler
Iowa
- Urology Center of Iowa Research — Clive
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2025-08-06 |
| Est. Completion | 2027-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06774131
The ClinicalTrials.gov registry entry for NCT06774131 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UroGen Pharma, which has 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Urothelial Carcinoma appearing as the primary indexed condition, and to 1 intervention — of which UGN-104 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06774131 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, South Carolina, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06774131 about?
NCT06774131 is a clinical study titled "A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer". This study will evaluate the efficacy and safety of UGN-104, a new formulation of UGN-101 (approved in the United States and Israel as JELMYTO \[mitomycin\] for pyelocalyceal solution), instilled in the upper urinary tract (UUT) of patients with low-grade upper tract urothelial cancer (LG-UTUC).
What is the current status of trial NCT06774131?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 70 participants. The study started on 2025-08-06. Estimated completion is 2027-10.
What conditions does trial NCT06774131 study?
This clinical trial studies the following conditions: Urothelial Carcinoma, Upper Urinary Tract Urothelial Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06774131?
The interventions under investigation include: UGN-104 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06774131?
This trial is sponsored by UroGen Pharma, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06774131 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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